british standard bs en...the text of document 62b/673/fdis, future edition 2 of iec 60601-1-3,...

BRITISH STANDARD BS EN 60601-1-3:2008

Medical electrical equipment —Part 1-3: General requirements for basic safety and essential performance — Collateral Standard: Radiation protection in diagnostic X-ray equipment

ICS 11.040.50; 13.280

��

Incorporating+A1:2013

corrigenda March 2010 and May 2014

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National foreword

This British Standard is the UK implementation of EN 60601-1-3:2008+A1:2013, incorporating corrigenda March 2010 and May 2014. It is identical to IEC 60601-1-3:2008, incorporating amendment 1:2013. It supersedes BS EN 60601-1-3:2008, which will be withdrawn on 24 May 2016.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to IEC text carry the number of the IEC amendment. For example, text altered by IEC amendment 1 is indicated by !".The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/2, Diagnostic imaging equipment.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.

BS EN 60601-1-3:2008+A1:2013

This British Standard waspublished under the authorityof the Standards Policy andStrategy Committeeon 30 September 2008

Amendments/corrigenda issued since publication

Date Comments

31 July 2010 Implementation of CENELEC corrigendum March 2010.Date of withdrawal added to Foreword

31 July 2013 Implementation of IEC amendment 1:2013 with CENELEC endorsement A1:2013. Annex ZA updated

30 June 2014 Implementation of CENELEC corrigendum May 2014: Date of withdrawal updated in the Foreword and Foreword to amendment A1

ISBN 978 0 580 86914 3

© The British Standards Institution 2014. Published by BSI Standards Limited 2014



EUROPEAN STANDARD EN 60601-1-3 NORME EUROPÉENNE

EUROPÄISCHE NORM

CENELEC European Committee for Electrotechnical Standardization

Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 60601-1-3:2008 E

ICS 11.040.50; 13.280

English version

Medical electrical equipment - Part 1-3: General requirements for basic safety

and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

(IEC 60601-1-3:2008) Appareils électromédicaux - Partie 1-3: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Radioprotection dans les appareils à rayonnement X de diagnostic (CEI 60601-1-3:2008)

Medizinische elektrische Geräte - Teil 1-3: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Strahlenschutz von diagnostischen Röntgengeräten (IEC 60601-1-3:2008)

This European Standard was approved by CENELEC on 2008-03-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.

:2008+A1

June 2013

Incorporating corrigenda March 2010 and May 2014



Foreword

The text of document 62B/673/FDIS, future edition 2 of IEC 60601-1-3, prepared by SC 62B, Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-1-3 on 2008-03-01.

The following date was fixed:

– latest date by which the EN has to be implementedat national level by publication of an identicalnational standard or by endorsement (dop) 2008-12-01

This European Standard supersedes EN 60601-1-3:1994.

This EN 60601-1-3 has been restructured and aligned to EN 60601-1:2006 and focussed on general requirements for RADIATION PROTECTION that apply to all diagnostic X-RAY EQUIPMENT. Requirements particular to specific equipment have been removed and will be covered in particular standards. For a description of the changes, see the mapping in Annex C.

This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ.

This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to as the general standard.

In the 60601 series of publications, collateral standards specify general requirements for safety applicable to:

– a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. RADIOLOGICAL equipment); or

– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the generalstandard (e.g. alarm systems).

In this collateral standard, the following print types are used:

− requirements and definitions: in roman type;

− test specifications: in italic type;

− informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type;

− TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTED: IN SMALL CAPITALS.

In referring to the structure of this standard, the term

– “clause” means one of the thirteen numbered divisions within the table of contents, inclusive of allsubdivisions (e.g. Clause 7 includes Subclauses 7.1, 7.2, etc.);

– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses ofClause 7).

References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this standard are by number only.

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true.

– 2 –

– latest date by which the national standards conflictingwith the EN have to be withdrawn (dow) 2018-12-31

BS EN 60601-1-3:2008+A1:2013EN 60601-1-3:2008+A1:2013 (E)



The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb

− “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard;

− “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard;

− “may” is used to describe a permissible way to achieve compliance with a requirement or test.

Clauses, subclauses and definitions for which a rationale is provided in informative Annex A are marked with an asterisk (*).

Annexes ZA and ZZ have been added by CENELEC.

__________

Endorsement notice

The text of the International Standard IEC 60601-1-3:2008 was approved by CENELEC as a European Standard without any modification.

__________

– 3 –

The text of document 62B/895/CDV, future amendment 1 to edition 2 of IEC 60601-1-3, prepared by SC 62B "Diagnostic imaging equipment" of IEC TC 62 "Electrical equipment in medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-1-3:2008/A1:2013. The following dates are fixed:

• latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement

(dop) 2014-02-24

• latest date by which the national standards conflicting with the document have to be withdrawn

(dow)

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).

Endorsement notice

The text of the International Standard IEC 60601-1-3:2008/A1:2013 was approved by CENELEC as a European Standard without any modification.

Foreword to amendment A1

BS EN 60601-1-3:2008+A1:2013 EN 60601-1-3:2008+A1:2013 (E)

2018-12-31



CONTENTS

INTRODUCTION..................................................................................................................... 7 1 Scope, object and related standards.................................................................................8

1.1 Scope......................................................................................................................8 1.2 Object .....................................................................................................................8 1.3 Related standards ...................................................................................................8

1.3.1 IEC 60601-1 ................................................................................................8 1.3.2 Particular standards ....................................................................................8

2 Normative references .......................................................................................................9 3 Terms and definitions ..................................................................................................... ..9 4 General requirements .....................................................................................................19

4.1 Statement of compliance ....................................................................................... 19 4.2 Composition of reference materials ....................................................................... 19

5 ME EQUIPMENT identification, marking and documents ..................................................... 19 5.1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts ............................ 19

5.1.1 General ..................................................................................................... 19 5.1.2 Marking requirements in subclauses ..........................................................19

5.2 ACCOMPANYING DOCUMENTS.................................................................................... 19 5.2.1 References in subclauses..........................................................................20 5.2.2 Dosimetric calibration ................................................................................ 20 5.2.3 General requirements for the reference of subassemblies and

ACCESSORIES..............................................................................................20 5.2.4 Instructions for use .................................................................................... 21

6 RADIATION management ..................................................................................................22 6.1 General .................................................................................................................22 6.2 Initiation and termination of the IRRADIATION ..........................................................23

6.2.1 Normal initiation and termination of the IRRADIATION................................... 23 6.2.2 Safety measures against failure of normal termination of the

IRRADIATION................................................................................................23 6.3 RADIATION dose and RADIATION QUALITY..................................................................23

6.3.1 Adjustment of RADIATION dose and RADIATION QUALITY ................................ 23 6.3.2 Reproducibility of the RADIATION output ......................................................23

6.4 Indication of operational states ..............................................................................24 6.4.1 Indication of the X-RAY SOURCE ASSEMBLY selected .................................... 24 6.4.2 Indication of LOADING STATE .......................................................................24 6.4.3 Indication of LOADING FACTORS and MODES OF OPERATION............................ 24 6.4.4 Indication of automatic modes ...................................................................24 6.4.5 Dosimetric indications................................................................................ 25

6.5 AUTOMATIC CONTROL SYSTEM ..................................................................................25 6.6 SCATTERED RADIATION reduction .............................................................................25 6.7 Imaging performance .............................................................................................25

6.7.1 General .....................................................................................................25 6.7.2 System performance..................................................................................25 6.7.3 Nominal focal spot value............................................................................26 6.7.4 RADIATION DETECTOR or X-RAY IMAGE RECEPTOR ..........................................26

7 RADIATION QUALITY ..........................................................................................................26

– 4 –BS EN 60601-1-3:2008+A1:2013EN 60601-1-3:2008+A1:2013 (E)



7.1 HALF-VALUE LAYERS and TOTAL FILTRATION in X-RAY EQUIPMENT ............................... 26 7.2 Waveform of the X-RAY TUBE VOLTAGE................................................................ 27 7.3 Indication of FILTER properties ...............................................................................27 7.4 Test for FILTRATION by irremovable materials .........................................................28 7.5 Test for ADDED FILTERS and materials.....................................................................28 7.6 Test for HALF-VALUE LAYER .....................................................................................28

8 Limitation of the extent of the X-RAY BEAM and relationship between X-RAY FIELD and IMAGE RECEPTION AREA .............................................................................................28 8.1 General .................................................................................................................28 8.2 Enclosure of X-RAY TUBES ......................................................................................28 8.3 Limiting DIAPHRAGM in X-RAY TUBE ASSEMBLIES ....................................................... 29 8.4 Confinement of EXTRA-FOCAL RADIATION ................................................................. 29 8.5 Relationship between X-RAY FIELD and IMAGE RECEPTION AREA ...............................29

8.5.1 General ..................................................................................................... 29 8.5.2 * FOCAL SPOT TO IMAGE RECEPTOR DISTANCE ................................................ 29 8.5.3 Correspondence between X-RAY FIELD and EFFECTIVE IMAGE

RECEPTION AREA ......................................................................................... 29 8.5.4 Positioning of the PATIENT and restriction of the irradiated area.................. 30

9 FOCAL SPOT TO SKIN DISTANCE..........................................................................................30 9.1 General .................................................................................................................30 9.2 Information in the ACCOMPANYING DOCUMENTS ........................................................30

10 ATTENUATION of the X-RAY BEAM between the PATIENT and the X-RAY IMAGE RECEPTOR .......................................................................................................................30 10.1 General .................................................................................................................30 10.2 Information in the ACCOMPANYING DOCUMENTS ........................................................30

11 Protection against RESIDUAL RADIATION ............................................................................31 12 * Protection against LEAKAGE RADIATION ..........................................................................31

12.1 General .................................................................................................................31 12.2 Mounting of X-RAY SOURCE ASSEMBLIES and X-RAY IMAGING ARRANGEMENTS ............ 31 12.3 Statement of reference LOADING conditions............................................................ 32 12.4 LEAKAGE RADIATION in the LOADING STATE ...............................................................32 12.5 LEAKAGE RADIATION when not in the LOADING STATE ................................................33

13 Protection against STRAY RADIATION ................................................................................33 13.1 General .................................................................................................................33 13.2 Control of X-RAY EQUIPMENT from a PROTECTED AREA..............................................33 13.3 Protection by distance ...........................................................................................34 13.4 * Designated SIGNIFICANT ZONES OF OCCUPANCY .....................................................34 13.5 Handgrips and control devices .............................................................................. 35 13.6 * Test for STRAY RADIATION .....................................................................................35

Annex A (informative) General guidance and rationale......................................................... 37 Annex B (normative) Values of the series R'10 and R'20, ISO 497 .......................................39 Annex C (informative) Mapping between this Edition 2 of IEC 60601-1-3 and Edition 1 ........ 40

Bibliography.......................................................................................................................... 42 Index of defined terms used in this collateral standard .......................................................... 44

– 5 –

Annex ZA (normative) Normative references to international publications with their corresponding European publications ....................................................................48

Annex ZZ (informative) Coverage of Essential Requirements of EC Directives ................... 49

BS EN 60601-1-3:2008+A1:2013 EN 60601-1-3:2008+A1:2013 (E)



Figure 1 – Example of presentation of data on STRAY RADIATION ............................................36 Table 1 – Subclauses containing requirements for marking ................................................... 19 Table 2 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS ............................. 20 Table 3 – HALF-VALUE LAYERS in X-RAY EQUIPMENT.................................................................27

– 6 –BS EN 60601-1-3:2008+A1:2013EN 60601-1-3:2008+A1:2013 (E)



INTRODUCTION

The requirements in this collateral Standard concern protective measures to be taken by the MANUFACTURER in the design and construction of medical diagnostic X-RAY EQUIPMENT and its subassemblies. They relate to the application of the X-RADIATION generated, both deliberately and incidentally, in fulfilling the medical purpose of the EQUIPMENT. Additional measures are necessary to regulate the generation processes themselves. These are described in the general requirements for safety, IEC 60601-1, and, where appropriate, in particular requirements for the EQUIPMENT concerned. The second edition of this collateral standard is focused on general requirements for RADIATION PROTECTION. The aim of the revision was to restrict to those requirements that apply to all diagnostic X-RAY EQUIPMENT. In consequence, most of the clauses have been reduced compared with the first edition of this standard, owing to the exclusion of content specific to projection RADIOGRAPHY and RADIOSCOPY. Implementation shall be considered in the RISK MANAGEMENT process or by using particular standards.

The recommended principles governing the use of RADIATION for medical purposes, as stated in Publication 60 of the International Commission on Radiological Protection (ICRP)[17]1), Chapter 4, have been taken into account. The implementation of these principles is essentially determined in the prevailing circumstances at the point of use. It requires judgements to be made by the user and the establishment of measures and working practices part of which are connected with the construction of EQUIPMENT. The requirements in this collateral Standard are intended to be consistent with generally accepted good practice in the administration of X-RADIATION in medicine.

In some cases, the formulation of the requirements is deliberately designed to provide scope for accommodating local laws and regulations at the time of installation and commissioning. Several of the requirements include provisions for relevant technical information to be included in ACCOMPANYING DOCUMENTS.

RESPONSIBLE ORGANIZATIONs for medical diagnostic X-RAY EQUIPMENT should be aware that effective protection against IONIZING RADIATION requires the consideration of many aspects additional to the construction of the EQUIPMENT. Among these are the following:

• compatibility of components and correct installation of EQUIPMENT;

• the protective properties of rooms where X-RAY EQUIPMENT is installed;

• measures for monitoring and maintaining the safety and effectiveness of EQUIPMENT throughout its life, with particular attention to components that can deteriorate progressively with time and use;

• the need in appropriate circumstances for PROTECTIVE CLOTHING to be worn by staff and for suitable devices to be used to protect PATIENTS;

• the keeping of appropriate records concerning the usage of the EQUIPMENT and the results of tests, with systematic review and the application of corrective action when necessary;

• the training of staff in the principles of RADIATION PROTECTION and in the correct use of EQUIPMENT, including any PROTECTIVE DEVICES provided.

Further advice on these aspects can be found in ICRP Publications 33[15], 34[16], 60[17], 73[18], 85[21], 87[22] and 93[23].

Readers of this collateral standard are reminded that, in accordance with IEC 60601-1, Clause 5, all the test procedures described are TYPE TESTS, intended to be carried out in a dedicated testing environment in order to determine compliance. Tests to be carried out by MANUFACTURERS to ensure compliance during production or installation and tests for detecting non-compliance subsequently to delivery, are not included.

————————— 1) Figures in square brackets refer to the Bibliography.

– 7 –BS EN 60601-1-3:2008+A1:2013 EN 60601-1-3:2008+A1:2013 (E)



MEDICAL ELECTRICAL EQUIPMENT –

Part 1-3: General requirements for basic safety and essential performance –

Collateral Standard: Radiation protection in diagnostic X-ray equipment

1 Scope, object and related standards

1.1 Scope

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

This collateral standard applies to X-RAY EQUIPMENT and to subassemblies of such equipment, where RADIOLOGICAL IMAGES of a human PATIENT are used for diagnosis, planning or guidance of medical procedures.

1.2 Object

The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.

The object of this collateral standard is to establish general requirements for protection against X-RADIATION in X-RAY EQUIPMENT, in order that the IRRADIATION of the human PATIENT, the OPERATOR, staff and members of the public can be kept as low as reasonably achievable, without jeopardizing the benefit of the RADIOLOGICAL procedure. Particular standards may specify their appropriate values and/or measures for general requirements specified in this collateral standard. The implementation of the general requirements or the reference to the particular standard instead, shall be justified in the RISK MANAGEMENT process.

This collateral standard considers RADIATION PROTECTION aspects related to X-RADIATION only.

Requirements for the control of the electrical energy used to generate X-RADIATION, which is also an important aspect of RADIATION PROTECTION, are included in IEC 60601-1 and in particular standards for the safety and ESSENTIAL PERFORMANCE of the EQUIPMENT concerned.

1.3 Related standards

1.3.1 IEC 60601-1

For ME EQUIPMENT and ME SYSTEMS, this collateral standard complements IEC 60601-1.

When referring to IEC 60601-1 or to this collateral standard, either individually or in combination, the following conventions are used:

•

•

• "this standard" designates the combination of the general standard and this collateral standard.

1.3.2 Particular standards

A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard.

– 8 –

!“the general standard” designates IEC 60601-1:2005+A1:2012;"

!“this collateral standard” designates IEC 60601-1-3:2008+A1:2013;"

BS EN 60601-1-3:2008+A1:2013EN 60601-1-3:2008+A1:2013 (E)



british standard bs en...the text of document 62b/673/fdis, future edition 2 of iec 60601-1-3,...

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